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港股异动 石药集团(01093)尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
Jin Rong Jie· 2025-12-17 09:15
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has seen an increase of nearly 3% towards the end of trading, currently up by 2.04% at HKD 7.51, with a trading volume of HKD 408 million [1] Group 1: Clinical Application Approval - CSPC Pharmaceutical's wholly-owned subsidiary, CSPC Ouyi Pharmaceutical Co., Ltd., has had its clinical application for Beipiduo Acid Tablets accepted by the China National Medical Products Administration (CDE) [1] - Beipiduo Acid is an ATP-citrate lyase inhibitor primarily used to lower low-density lipoprotein cholesterol (LDL-C) in adult patients who cannot tolerate statin therapy, reducing the risk of myocardial infarction and coronary artery revascularization [1] Group 2: Market Potential - Beipiduo Acid was first approved for market in the United States by the FDA in 2020 [1] - Market analysts estimate that Beipiduo Acid Tablets could capture up to 25% of the cholesterol medication market, with peak sales expected to reach between USD 2 billion to USD 3 billion [1] - Currently, no original or generic versions of Beipiduo Acid Tablets have been launched in the domestic market, with four companies, including CSPC Ouyi Pharmaceutical, having their clinical applications accepted, indicating the start of a competition for the first generic [1]
港股异动 | 石药集团(01093)尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
智通财经网· 2025-12-17 08:12
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose nearly 3% towards the end of trading, with a current increase of 2.04%, priced at HKD 7.51, and a trading volume of HKD 408 million [1] Group 1: Clinical Application Approval - CSPC Pharmaceutical's wholly-owned subsidiary, CSPC Ouyi Pharmaceutical Co., Ltd., has had its clinical application for Beipaidu Acid Tablets accepted by the China National Medical Products Administration (NMPA) [1] - Beipaidu Acid is an ATP-citrate lyase inhibitor used to lower low-density lipoprotein cholesterol (LDL-C) in adult patients who cannot tolerate statin therapy, reducing the risk of myocardial infarction and coronary artery revascularization [1] Group 2: Market Potential - Beipaidu Acid was first approved by the FDA in the United States in 2020, and market analysts estimate that it could capture up to 25% of the cholesterol medication market, with peak sales expected to reach between USD 2 billion to USD 3 billion [1] - Currently, no original or generic versions of Beipaidu Acid Tablets have been launched in the domestic market, with four companies, including CSPC Ouyi Pharmaceutical, having their clinical applications accepted, indicating the start of a first-to-market competition [1]
石药集团尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
Zhi Tong Cai Jing· 2025-12-17 08:09
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose nearly 3% towards the end of trading, currently up 2.04% at HKD 7.51, with a trading volume of HKD 408 million [1] Group 1: Clinical Application Approval - CSPC Pharmaceutical's wholly-owned subsidiary, CSPC Ouyi Pharmaceutical Co., Ltd., has received acceptance for the clinical application of Beipiduo Acid Tablets, classified as a Class 3 chemical drug by the China National Medical Products Administration (NMPA) [1] - Beipiduo Acid is an ATP-citrate lyase inhibitor primarily used to lower low-density lipoprotein cholesterol (LDL-C) in adult patients who cannot tolerate statin therapy, reducing the risk of myocardial infarction and coronary artery revascularization [1] Group 2: Market Potential - Beipiduo Acid was first approved for marketing by the FDA in the United States in 2020, and market analysts estimate that it could capture up to 25% of the cholesterol medication market, with peak sales expected to reach between USD 2 billion to USD 3 billion [1] - Currently, no original or generic versions of Beipiduo Acid have been launched in the domestic market, but four companies, including CSPC Ouyi Pharmaceutical, have had their clinical applications accepted, indicating the start of a competition for the first generic version [1]
立方制药丹皮酚原料药获批上市 产品结构进一步丰富
Zheng Quan Ri Bao Wang· 2025-06-30 13:03
Group 1 - The core point of the article is that Hefei Lifan Pharmaceutical has received approval for the production of Danpi Phenol, which enhances its raw material supply capacity and competitiveness in the market [1] - The new production process for Danpi Phenol is environmentally friendly and cost-effective, allowing for capacity expansion while meeting market demand [1] - The approval of Danpi Phenol is part of a series of product approvals this year, including the approval for the raw material of Docusate Sodium, which further enriches the company's product pipeline [1] Group 2 - The company has also received a clinical trial approval for Beipiduo Acid Tablets, marking a significant step in the development of lipid-lowering drugs and establishing a foundation for expansion in the cardiovascular treatment market [2] - Beipiduo Acid Tablets were originally approved in the U.S. in 2020, and Lifan Pharmaceutical is the third company in China to receive clinical approval, providing it with a first-mover advantage in this field [2] - The biopharmaceutical industry is projected to grow significantly, with the market size expected to reach 2.24 trillion yuan by 2025, indicating a competitive landscape where companies with core technologies and innovation capabilities are likely to succeed [2]
立方制药:收到药品临床试验批准通知书
news flash· 2025-04-24 09:31
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of Beipaidu Acid Tablets, a drug aimed at lowering LDL-C by inhibiting cholesterol synthesis in the liver [1] Group 1: Product Information - Beipaidu Acid Tablets are classified as a Class 3 chemical drug in the registration application [1] - The original drug was approved for market release in the United States in 2020 and has not yet been launched domestically [1] Group 2: Company Position - The company is the third domestic enterprise to receive approval for clinical trials of this drug [1] - The approval of the clinical trial application is not expected to have a significant impact on the company's short-term performance [1]